Many medical procedures, such as the administration of drugs (e.g., sedative and analgesic drugs) are safety-critical tasks with patient health at issue. Therefore, identification and certification of the origin and manufacturer of medical supplies and the identification of drugs to be administered to a patient is important. Such identification and certification enhances patient safety by ensuring and enhancing the quality of pharmaceuticals and single-patient use disposable devices, including assuring such criteria as proper purity, concentration, sterility, calibration, and manufacturing tolerance.
Also important are means for preventing medical supplies having already been used with one patient from being subsequently reused with another patient. Cross-contamination between patients is a concern because of infectious diseases caused by blood-borne pathogens such as the Human Immunodeficiency Virus (HIV) and hepatitis B and C, and by respiratory pathogens such as multi-drug resistant tuberculosis. Further, contamination of certain pharmaceuticals have caused fatal cases of septicemia because these compounds support the growth of bacteria.
In an attempt to prevent cross-contamination, medical equipment, components and supplies are often sterilized prior to reuse with a different patient. However, recent studies indicate that sterilization of many medical devices, especially those that have valves, complex mechanisms, or narrow and long lumens (e.g., laparoscopic trocars, endoscopic biopsy forceps, and fiberscopes), may not be entirely effective.
An alternative way to avoid cross-contamination is through single patient use (disposable) medical supplies and components. Disposable medical supplies and components will not prevent cross-contamination if they are reused. Therefore, concerns remain as to both the deliberate and the unintentional reuse of disposable medical supplies and components. There is also concern beyond patient cross-contamination with the unauthorized sterilization and/or reuse of disposable medical supplies and components which are not designed or validated to be sterilized or to have a long service life.
Goods that outwardly and superficially look like a component or supply of a medical device having the appropriate form, fit, and function to be used with the device may actually be uncertified products that were otherwise not manufactured according to original design specifications. In many circumstances where quality and reliability of performance are mission-critical, the customer or other user may not be able to discern the difference between uncertified and genuine parts. For example, proper use of a drug administration or infusion system requires knowledge of the drug concentration, dead space volume in the infusion tubing and drug pump cassette, and calibrated tubing and compression surfaces (in order to generate volumetric control of the rate of drug infusion). This information may not be known or be outside the specifications for uncertified versions of components or supplies of infusion systems.
If medical supplies were “smart,” the detection of the presence or absence of certified medical supplies and their use-condition could be easily automated. Automation may also relieve the clinician of the chore and memory load of certifying products and may enhance patient safety by ensuring that all necessary supplies are present and where appropriate, unused, before the initiation of a medical procedure.
Further, despite the best quality assurance efforts of manufacturers, contaminated or defective products sometimes reach the marketplace. Ensuing product recalls are an extremely costly endeavor for the manufacturer. An identification system that would facilitate localization and removal of every single recalled product would be advantageous. As an added safety measure, it would be beneficial if the batch number and unique identification numbers of the recalled products could be programmed into the associated delivery device, like a conscious sedation machine, or at any dispensing location like a pharmacy or a centralized database so that any recalled product, such as a tainted drug vial, slipping through the recall is rejected by the delivery device.